Certificate of Analysis (COA)
A Certificate of Analysis (COA) is a document issued by a manufacturer or a supplier of a product that certifies the quality and purity of the product. COAs provide detailed information on the composition, properties, and test results of a product, and are typically required by customers or regulatory agencies as evidence of product quality and compliance.
COAs typically include the
following information:
1.
Product identification: This includes the product name,
batch or lot number, and the date of manufacture.
2.
Composition: This includes a list of the product's
ingredients or components, including their concentration or quantity.
3.
Specifications: This includes the product's physical,
chemical, and microbiological properties, as well as any other relevant
specifications or standards that the product is expected to meet.
4.
Test results: This includes the results of any tests
performed on the product to confirm its quality, purity, and potency, as well
as any other relevant test data.
5.
Analytical methods: This includes a description of the
analytical methods used to test the product, as well as any relevant validation
data.
6.
Quality control: This includes information on the quality
control measures taken during the manufacturing process to ensure the product
meets predefined specifications and acceptance criteria.
COAs are typically issued
by the manufacturer or supplier of the product, and are often required by
regulatory agencies, such as the FDA, as part of the product approval process.
COAs can also be requested by customers or other third parties as a means of
verifying product quality and compliance.
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